EMA数据库中的新版GMP的不合格报告

清歌一曲月如霜

欧洲药品管理局（EMA）已经建立，其中包含GMP和GDP的合规性信息的数据库。这个数据库被称为EudraGMDP。一段时间以来均线也已出版GMP和GDP的非合规报告。有些报告涵盖API的生产基地，覆盖其他生产基地的医药产品。从有关生产基地的产品不应该被使用，直到符合GMP再次保证。如果国内生产总值不遵守报告已组织不再允许分销医药产品或API。
英国药物权威MHRA已issed为WOCKHARDT有限公司在印度Aurangabad一个GMP非合规报告。一些Wockhardt公司的经营已经受到审查通过美国FDA认证。欧盟数据库中的当前项是指一些关键和主要结果。 “一个关键的缺陷被引用关于GMP的记录数据的完整性，项目被视为作出时，工作人员不在场的现场，文档被认为尽管看似以这种方式完成的，这不是同时地完成。第二个关键缺陷被引用的关于潜在的产品污染，这包括使用不合适的材料接近的产品，如石棉涂PTFE密封的离心机巷道的“。除重大缺陷如对设施的维护，设计和认证也已确定。该MHRA指出，“目前没有GMP证书实行了这个API服务。受限制的GMP证书将发给许可证的产品被认为是医学上重要的持续测试，由国家主管机关确定。国家主管部门应要求营销授权人进行风险评估，以风险评估为从发现的问题产品质量和病人“。
就在最近的MHRA出版了GMP的非合规的摩菲制药在报告伦敦（英国），其中包含了一些研究用药品（IMPS）的。该报告指出：“涉及到无菌保证，灭菌工艺和药品质量体系的严重缺陷已经确定在摩菲制药担忧拖累无菌的准备各个方面，并最终灭菌产品的故障和违规鉴定的方法来鉴定灭菌的日常监控。可怜无菌做法被注意到的制造工艺。A级HEPA过滤器的完整性失败已经注意到部分地区。微生物环境监测和媒体模拟程序有缺陷。媒体模拟故障已经确定。严重的不足之处，指出与药品质量体系。公司纠正和预防行动和整治，到今天为止，都未能充分解决所有的缺陷和违规，目前市场上还没有证据显示非无菌产品，大部分未经授权的医药产品有体积小保质期短，且不受无菌试验。一个监控的风险评估，通过快速警报分发。 “
意大利AIFA机构已颁布的GMP非合规报告SIMSSocietà与Italiana的Medicinali斯堪srl公司位于雷杰洛，意大利。据AIFA检查在API生产商是在暗访与意大利警察当局和意大利海关当局合作。 AIFA发现其中包括用于存储从中国进口的材料中两未经许可，不是GMP的存储区域（声明为办公区）。也有不符合GMP的重新包装站被发现。
在马耳他主管机关发现一个批发分销商不遵守要求的国内生产总值谁。此外，该公司负责做买卖伪造药品（不包括从合法供应链购买）。批发经销商的执照被吊销。

清歌一曲月如霜

The European Medicines Agency (EMA) has established a database which contains GMP and GDP compliance information. This database is called EudraGMDP. For some time now the EMA has also been publishing GMP and GDP Non-Compliance Reports. Some reports cover API manufacturing sites, others cover manufacturing sites for medicinal products. Products from the concerned manufacturing sites should not be used until the GMP compliance is guaranteed again. If a GDP Non-Compliance report has been issued the organisation is no longer allowed to distribute medicinal products or APIs.
The UK Medicines authority MHRA has issed a GMP Non-Compliance Report for WOCKHARDT LIMITED in AURANGABAD, India. A number of Wockhardt operations have already been under scrutiny by US FDA. The current entry in the EU database refers to a number of critical and major findings. "A critical deficiency was cited with regard to data integrity of GMP records, entries were seen to be made when personnel were not present on site, documentation was seen that was not completed contemporaneously despite appearing to be completed in this manner. A second critical deficiency was cited regarding potential product contamination. This included the use of inappropriate materials close to product, e.g. asbestos coated PTFE seals for centrifuge manways." In addition major deficiencies e.g. on facility, maintenance, design and qualification have been identified. The MHRA states "There are no current GMP certificates in place for this API facility. A restricted GMP certificate will be issued to permit continued testing of products considered to be medically critical, as determined by the national competent authority. National competent authorities should request marketing authorisation holders to conduct a risk assessment to evaluate the risk to product quality and patients from the issues identified".
Just recently the MHRA has published a GMP Non-Compliance Report for MOORFIELDS PHARMACEUTICALS in London (UK) which contains a number of Investigational Medicinal Products (IMPs). The report states: "Serious deficiencies related to sterility assurance, sterilisation processes and the Pharmaceutical Quality System have been identified at Moorfields Pharmaceuticals. Concerns implicate all aspects of aseptically prepared and terminally sterilised products. Failures and non-compliances were identified with the approach to qualification and the routine controls of sterilisation. Poor aseptic practices were noted with manufacturing processes. Grade A HEPA filter integrity failures have been noted for some areas. Microbiological environmental monitoring and media simulation programmes were deficient. Media simulation failures have been identified. Serious deficiencies were noted with the Pharmaceutical Quality System. Company Corrective and Preventative actions and remediation, to date, have failed to adequately address all deficiencies and non-compliances. There is currently no evidence of non-sterile product on the market. Most unauthorised medicinal products are small volume short shelf life, and not subject to sterility testing. A supervisory risk assessment has been circulated via rapid alert. "
The Italian Agency AIFA has issued a GMP Non-Compliance Report for SIMS Società Italiana Medicinali Scandicci srl located in Reggello, Italy. According to AIFA the inspection at the API manufacturer was unannounced in collaboration with Italian police authorities and Italian custom authorities. AIFA found two unauthorized, not-GMP storage areas (declared as office area) among others used for storage of imported materials from China. Also a not compliant GMP repackaging station was found.
In Malta the competent authority found a wholesale distributor who did not comply with GDP requirements. Moreover, the company was made responsible for trading in falsified medicinal products (not purchased from legal supply chain). The wholesale dealer's license was revoked.

sunfly

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xqliu

学习一下啦，谢谢提供分享。